Principal Scientist, Drug Product & Analytical Development

Position Overview:

We are seeking an experienced and driven Principal Scientist, Drug Product & Analytical Development to participate in late-stage clinical and commercial manufacturing and analytical method development and method validation, serving as a dual role for intranasal drug products. The successful candidate will oversee the development, optimization, and validation of nasal spray-specific analytical methods, manage outsourced manufacturing and testing activities at contract manufacturers (CDMOs), and serve as the drug product/analytical representative on all CMC teams. This individual will also contribute technical expertise across multiple programs, benchmark industry trends, and lead the production of registration batches.

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Senior Vice President, Head of CMC.

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

Provide strategic direction and oversight for drug product development and analytical testing activities.
Represent the Analytical and Drug Product functions on the CMC teams, ensuring alignment with program goals and timelines.
Lead cross-functional initiatives and contribute to departmental strategy and planning.
Ensure timely delivery of technical drug product (nasal spray) milestones, including process development, tech transfer, cGMP production, stability studies, process characterization (QbD), and validation.
Oversee manufacturing of registration batches in alignment with regulatory and quality standards.
Coordinate closely with CMOs for manufacturing and CROs for analytical testing, including onboarding and technical transfer to new vendors.
Lead development and validation of both nasal spray-specific analytical methods as well as general chromatography methods.
Ensure all analytical testing is conducted in compliance with regulatory expectations (ICH, FDA) and internal quality standards.
Provide technical oversight of CRO activities and ensure successful method transfer and implementation.
Serve as a technical resource for strategic decision making, risk assessment, and mitigation planning.
Monitor industry trends and implement innovative technologies to enhance nasal spray drug product development and testing.
Contribute technical expertise across multiple projects and programs, supporting cross-functional collaboration.
Author and review technical documentation, including protocols, reports, test methods, SOPs, and regulatory submissions.
Ensure compliance with GMP and regulatory requirements throughout development and manufacturing processes.

Education & Experience

Master’s degree in Process Engineering or Pharmaceutical Sciences with 8–10 years of experience within a pharmaceutical or biotechnology company (direct sponsor experience required) OR
Ph.D. in a related field with 5–8 years of experience within a pharmaceutical or biotechnology company (direct sponsor experience required)

Qualifications:

Proficiency with typical nasal spray and/or inhalation product performance analytical tools (e.g. Particle Size analysis, Plume Geometry, Spray Pattern, Droplet Size Distribution, Actuation Force, etc.) as well as typical chromatographic analytical tools (e.g. PHLC-UV, LC-MS).
Thorough understanding of ICH, FDA, and other regulatory expectations for method validation, transfer, and GMP manufacturing and analytical testing.
Proficiency with utilizing typical literature searching techniques to solve nasal spray and/or inhalation drug product manufacturing and/or testing problems.
Extensive experience in CMC GMP pharmaceutical development including a proven track record of process scale up and validation.
Extensive experience in working with and outsourcing work to CROs and CMOs.
Advanced Microsoft Word, Excel, and PowerPoint functions. Experience with statistical software such as Jump or Prism.
Creative thinking and problem-solving skills in a standalone, multi-disciplinary environment with accountability for information department or functional strategy.

Compensation and Benefits

What we offer:

Industry competitive compensation
Performance-based bonuses
Stock options
Employee Stock Purchase Plan
401k plan
A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely:

Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
FSA and HAS
Basic Life Insurance 2x Earnings and AD&D
Employee Assistance Program
Healthcare advocates group to help navigate the healthcare system

Work-life balance:

Unlimited paid time off
Flexible work schedule
Remote work option
Paid holidays
Mental health days
Winter shutdown
Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $160,000-$190,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company’s 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands:

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and/or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer: VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee’s have rights under Federal Employment Laws and link to the three posters: Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

OVERVIEW OF THE COMPANY

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ: VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen’s neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen’s neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.vistagen.com.